Use of Platelet Rich Plasma from Cord Blood Vs Placebo in the Treatment of Vulvar Lichen Sclerosus

NCT ID: NCT06661382

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2024-12-24

Brief Summary

Vulvar lichen Sclerosus (VLS) is a cutaneous-mucosal dermatosis that causes in the adult female vulvar itching and burning due to scratching abrasions. Dyspareunia is often associated . The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. The placement of VLS in the context of immune-mediated dermatoses is the basis of the rationale for treatment with high potency topical corticosteroids. However, in some cases, local corticosteroid therapy is not sufficient resulting in a significant impact on the quality of life of the patient. This gives rise to the need to identify new treatments such as regenerative medicine.

The term PRP (Platelet Rich Plasma) is used to describe a blood product generated by a two-step centrifugation process of whole blood of a patient to produce a concentration of platelets in a small volume of plasma. PRP can be produced from autologous, homologous blood or from cord blood (CB-PRP).

Our objective is to evaluate the efficacy of CB-PRP versus placebo in the treatment of VLS.

Detailed Description

Lichen Sclerosus (LS) is a cutaneous-mucosal dermatosis characterized by chronic changes in the trophism and maturation of the epithelium and the connective tissue. In females, the vulvar region is affected in about 90% of cases, often constituting the only site involved. In the adult female, the predominant symptoms are vulvar itching and burning due to scratching abrasions. Dyspareunia is an often associated. The clinical course is irregular but progressive and is characterized by periods of relative quiescence alternating with episodes of exacerbation of symptoms. The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. The placement of LS in the context of immune-mediated dermatoses is the basis of the rationale for treatment with high potency topical corticosteroids. However, in some cases, local corticosteroid therapy is not sufficient to achieve adequate compensation of the pathology, and significant changes may set in of the vulvar anatomy resulting in a significant impact on the quality of life of the patient. This gives rise to the need to identify new treatments such a regenerative medicine. The term PRP (Platelet Rich Plasma) is used to describe a blood product blood generated by a two-step centrifugation process of whole blood of a patient to produce a concentration of platelets in a small volume of plasma. In addition to platelets, PRP contains large amounts of chemical mediators that promote angiogenesis, recruitment and proliferation of cells implicated in tissue regeneration and healing. PRP can be produced from autologous, homologous (donor) blood or from cord blood (CB-PRP). The main difference between PRP from peripheral blood (PB-PRP) and that from cord blood concerns the relative amount of growth factors and pro- and anti-inflammatory molecules. CB-PRP has been shown to be advantageous from a therapeutic point of view compared with PB-PRP because it contains higher concentrations of anti-inflammatory molecules. In addition, the use of CB-PRP allows for a final product that is not conditioned by the patient's age and by any associated comorbidities, which may instead compromise the quality of PB-PRP. Finally, the advantages of CB-PRP are related to lower production costs and to the greater ease of product preparation. The preparation process of CB-PRP involves a collection of cord blood following the expulsion of the placenta. The blood is then centrifugated using a two-step process. The final product is then injected on the vulvar surface under vulvoscopic guidance. Treatment with PRP is free of any major side effects. The objective of the following study is to evaluate the efficacy of CB-PRP versus placebo in the treatment of VLS.

Conditions

Vulvar Lichen Sclerosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Infiltrative treatment with CB-PRP Group

Group Type: EXPERIMENTAL

Infiltrative treatment with CB-PRP

Intervention Type: BIOLOGICAL

Injection of CB-PRP or placebo into the vulvar site. Three treatments are planned four weeks apart. Three and six months after the last treatment with CB-PRP/ placebo each participant will be re-evaluated by vulvoscopy and biopsy, and will be given validated questionnaires to assess satisfaction, symptoms, and quality of life, psychological state, and sexual function.

Placebo infiltrative treatment Group

Group Type: PLACEBO_COMPARATOR

Infiltrative treatment with CB-PRP

Intervention Type: BIOLOGICAL

Injection of CB-PRP or placebo into the vulvar site. Three treatments are planned four weeks apart. Three and six months after the last treatment with CB-PRP/ placebo each participant will be re-evaluated by vulvoscopy and biopsy, and will be given validated questionnaires to assess satisfaction, symptoms, and quality of life, psychological state, and sexual function.

Interventions

Infiltrative treatment with CB-PRP

Injection of CB-PRP or placebo into the vulvar site. Three treatments are planned four weeks apart. Three and six months after the last treatment with CB-PRP/ placebo each participant will be re-evaluated by vulvoscopy and biopsy, and will be given validated questionnaires to assess satisfaction, symptoms, and quality of life, psychological state, and sexual function.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• women with VLS (clinical/histological diagnosis)
• good health conditions
• written informed consent signed and dated by the patient

Exclusion Criteria

• pregnancy
• coagulopathies, platelet disorders, cardiovascular and/or respiratory diseases
• ongoing major infections
• previous vulvar surgery (e.g., lipostructure and/or previous PRP)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Direzione Ginecologia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

veronica Boero, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Milan, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Veronica Boero, MD

Role: CONTACT

veronica.boero@policlinico.mi.it

0255032318

Facility Contacts

Veronica Boero, MD

Role: primary

veronica.boero@policlinico.mi.it

Giulia Cetera, MD

Role: backup

giuliaemily.cetera@gmail.com

Other Identifiers

FLIPP

Identifier Type: -

Identifier Source: org_study_id